NCT00169234

Pneumococcal Adult-dose Ranging Immunization Study

Immunogenicity and Safety of Varying Doses of a 7-valent Conjugate Pneumococcal Vaccine in Adults 70-79 Years of Age Who Were Previously Vaccinated With the 23-valent Pneumococcal Polysaccharide Vaccine

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Kaiser Permanente · Academic / Other
• Sex: All
• Age: 70 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to give seniors different doses of a new pneumococcal vaccine called PCV7 to evaluate the safety of the vaccine and compare the immune response to find out which amount gives the best immune response. The PCV7 vaccine is currently licensed by the FDA for use in infants and toddlers only.

Detailed description

The purpose of this prospective randomized study is to assess the safety, post-vaccination antibody response, and memory response to a subsequent polysaccharide challenge of varying doses of PCV7 compared with the standard dose of PPV23 in immunocompetent adults 70-79 years of age who were previously vaccinated with PPV23 at age 65 years or above and at least 5 years previously. The study will be conducted among a total of 220 persons recruited from GHC and the Seattle VAMC. Participants will be randomized into one of 5 study groups with 44 participants per group. The antigen content of PCV7 will be varied by administration of different volumes of the licensed pediatric formulation of that vaccine. Four groups will receive one of four volumes (0.1 mL, 0.5 mL, 1.0 mL, 2.0 mL) of the licensed pediatric formulation of PCV7 followed 12 months later by administration of a challenge 0.1 mL dose of PPV23 to assess the induction of immunologic memory. The comparison group will receive the standard 0.5 mL dose of PPV23 following 12 months later by administration of a 0.1 mL dose of PPV23.

Conditions

• Pneumonia

Interventions

Type	Name	Description
BIOLOGICAL	PCV7, Prevnar®	Randomized to receive 0.1mL, 0.5mL, 1.0mL or 2.0mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.
BIOLOGICAL	Pneumovax 23	Randomized to receive 0.5mL at the enrollment visit, followed by 0.1mL PPV23 12 months later.

Timeline

• Start date: 2003-05-01
• Primary completion: 2005-02-01
• Completion: 2005-02-01
• First posted: 2005-09-15
• Last updated: 2017-10-13

Locations

2 sites across 1 country: United States